United States District Court, D. Massachusetts
MEMORANDUM & ORDER
Talwani United States District Judge.
2010, Plaintiff Stephen Goodell was administered an injection
of Magnevist in connection with an MRI. Magnevist is a
gadolinium-based contrast agent (“GBCA”)
manufactured, marketed, and sold by Defendants Bayer
Healthcare Pharmaceuticals Inc., Bayer Corporation, and Bayer
Healthcare LLC (collectively “Bayer”). Plaintiff
alleges that the gadolinium from the 2010 injection remains
in his body and has caused him injury. Before the court is
Bayer’s Motion to Dismiss [#54]. Bayer
contests the court’s personal jurisdiction over Bayer.
Bayer also challenges Plaintiffs claims for relief, arguing
that: 1) Plaintiffs claims are preempted by federal law
regulating the labelling of Magnevist, 2) the complaint fails
to identify a cognizable injury and causally connect that
injury to Magnevist, 3) Plaintiff cannot obtain relief under
Massachusetts’ Consumer Protection Law because of a
statutory exemption for government-approved activity, 4)
Plaintiff does not have standing to seek injunctive relief,
and 5) that Plaintiffs claims are time-barred. The court
ALLOWS Bayer’s motion to dismiss for failing to
sufficiently allege personal jurisdiction over Bayer and
because the claims, as pleaded, are federally preempted.
However, Plaintiff is granted leave to amend the complaint.
Factual Background as Set Forth in the
2010, when Plaintiff was administered Magnevist, studies
showed that the specific type of GBCA contained in Magnevist
(linear GBCAs) was more likely than another type of GBCA
(macrocyclic GBCAs) to result in retention of gadolinium in
the body. First Amended Complaint ¶¶ 38-39 [#49]
(“Complaint”). However, the manufacturers of
Magnevist and other GBCAs did not share this information with
consumers or physicians. Compl. ¶ 46. Based on evidence
of an association between GBCAs and a type of kidney disease,
the FDA released a warning regarding the release of
gadolinium from linear GBCAs like Magnevist in 2007. Compl.
¶ 47. Defendants also revised the label for Magnevist at
that time to include a contraindication for use in people
with kidney disease and injury. Compl. ¶ 48.
2012 or 2013, researchers identified evidence that gadolinium
retention was connected to illness in patients with normal
kidney function. Compl. ¶¶ 52-57. In July 2015, the
FDA released a public safety alert that it was investigating
the risk of gadolinium retention from repeated use of GBCAs.
Compl. ¶ 55. In September 2017, after the FDA voted to
add concerns about gadolinium retention on warning labels,
GBCA manufacturers, including Defendants, issued a new joint
warning to patients with normal kidney function. Compl.
¶¶ 56-57. This warning communicated that gadolinium
is retained for months to years, even in healthy patients,
and that this retention was more pronounced with linear
GBCAs. The warning also directed physicians to advise
patients of these concerns. Compl. ¶ 57.
recently, members of the medical community generally were not
aware of any disease associated with gadolinium for patients
with normal kidney function. Compl. ¶ 50.
claims that Defendants failed to properly warn him of the
risks posed by linear GBCAs such as Magnevist in 2010 and
failed to communicate that there were safer alternatives
available (macrocylic GBCAs). Compl. ¶ 27. As a result
of being administered Magnevist, Plaintiff continues to have
detectable levels of gadolinium in his body. Compl. ¶
33. This retained gadolinium can result in fibrosis in
organs, skin, and bones, retained gadolinium in the brain,
and related injuries. Compl. ¶ 28. Plaintiff alleges
that the retained gadolinium has in fact caused him
“severe and permanent physical and emotional injuries,
including, but not limited to, gadolinium retention in
multiple organs . . . the resulting fibrosis in organs, bone,
and skin, and its tendency to cross the blood-brain barrier
and deposit in . . . the brain.” Compl. ¶ 88.
filed his initial Complaint [#1] in the Northern
District of California in October 2017. The parties agreed to
transfer venue to the District of Massachusetts, the district
in which Plaintiff stipulated that the Magnevist was
allegedly administered. Parties’ Stipulation 4-5 [#24].
However, Defendants expressly reserved the right to challenge
personal jurisdiction in this district. Id at 2. On
April 6, 2018, the case was transferred to this district
pursuant to 28 U.S.C. § 1406(a). Order [#25].
transfer, Plaintiff filed an Amended Complaint [#49]
and Defendants filed the pending Motion to Dismiss
[#54], which Plaintiff has opposed. Pl.’s Opp’n
assert first that the action must be dismissed for lack of
personal jurisdiction. Two types of personal jurisdiction are
recognized under the federal Constitution:
“‘general’ (sometimes called
‘all-purpose’) jurisdiction and
‘specific’ (sometimes called
Bristol-Myers Squibb Co. v. Super. Ct. of Cal., 137
S.Ct. 1773, 1780 (2017). Plaintiff concedes that the court
does not possess general jurisdiction over Bayer. Pl.’s
Opp’n 4 [#61]. For specific jurisdiction, the court
must consider: (1) whether the claims arise out of or are
related to the defendant’s in-state activities
(“relatedness”), (2) whether the defendant has
purposefully availed itself of the laws of the forum state
(“purposeful availment”), and (3) whether the
exercise of jurisdiction is reasonable under the
circumstances (“reasonableness”). Nowak v.
Tak How Investments, Ltd., 94 F.3d 708, 712-713 (1st
contends that an analysis of Massachusetts’ long-arm
statute is unnecessary since the bounds of the long-arm
statute are coterminous with the bounds of the federal
Constitution for the purpose of assessing personal
jurisdiction. Pl.’s Opp’n 4-5 [#61] (citing
cases). “But in recent cases, [the First Circuit] ha[s]
suggested that the Commonwealth's long-arm statute may
impose limits on the exercise of personal jurisdiction more
restrictive than those required by the Constitution.”
A Corp. v. All Am. Plumbing, Inc., 812 F.3d 54, 59
(1st Cir. 2016) (reviewing cases) (internal citation
omitted). Accordingly, in this diversity action, the court
must also consider the forum’s long-arm statute.
Sawtelle v. Farrell, 70 F.3d 1381, 1387 (1st Cir.
1995). In Massachusetts, that statute is Mass. Gen. Laws ch.
223A, § 3. Section 3(a), for example, provides
jurisdiction over companies “transacting any business
in this commonwealth.” Mass. Gen. Laws ch. 223 A,
§ 3(a). This section has been consistently interpreted
to require that the transactions occurring in this ...